TerminatedPhase 3

KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children

Stopped: NDA #210565 did not trigger the need for a Pediatric Research Equity Act study.

United States2 participantsStarted 2018-07-03

Plain-language summary

This study is designed to assess how KPI-121 1% compares to prednisolone acetate in reducing inflammation after cataract surgery in young children. Approximately half the participants will receive KPI-121 1% eye drops and the other half will receive prednisolone acetate.

Who can participate

Age range3 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Be a candidate for routine, uncomplicated cataract surgery Exclusion Criteria: * Have a post-traumatic cataract. * Have suspected permanent low vision or blindness in the fellow non-study eye. * Have active uveitis in either eye. * Have an ocular neoplasm in either eye. * Have the presence of viral, bacterial, or fungal disease in either eye. * Have glaucoma, ocular hypertension, steroid-induced IOP (intraocular pressure) rise or elevated IOP

What they're measuring

Anterior Chamber Cell Grade

Timeframe: Day 15

Trial details

NCT IDNCT03596723

SponsorKala Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-09-28

Results submitted2020-02-26

View on ClinicalTrials.gov More Ocular Inflammation trials